Hemodialysis, Renal Insufficiency, Chronic
Conditions
Keywords
medical device, connection medical device
Brief summary
The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections. Aim: The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use. Material and methods: This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month. Hypothesis tested: The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.
Detailed description
The incidence and prevalence of chronic insufficiency have been growing for several years. Increasingly older patients are treated with chronic hemodialysis. The vascular access of choice remains the arteriovenous fistula and the proportion of hemodialysis patients on the permanent central venous hemodialysis catheter varies from 20 to 35% in dialysis centres. The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections. Aim: The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use. Material and methods: This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month. Hypothesis tested: The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription. The secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations.
Interventions
DEVICEUPLUG Hemodialysis Connection Device
use of the device UPLUG during 1 month
Sponsors
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
feasibility study on medical device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* with end-stage chronic renal failure treated by hemodialysis (2 or 3 sessions per week) * Wearer of a right or left jugular permanent tunneled central venous hemodialysis catheter whose end has been in the superior vena cava or the right atrium for at least 1 month * Hemodialysis catheter lock used = heparin or 4% citrate * Expected life expectancy \> 6 months * Dialysis session preceding inclusion with an average blood flow of at least 300ml/min
Exclusion criteria
* Patient with a mechanical heart valve * Patient with an arteriovenous fistula (AVF) that can be used within one month * Kidney transplant by living donor planned in the following month * Pregnant or breastfeeding woman * History of infection on the hemodialysis catheter in place dating from less than 6 months * Psychiatric or demented patient unable to obtain informed consent * Patient already included in another protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success in performing dialysis | one month | Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG | one month | adverse events reported from consent to end of study |
| experimental device integrity | one month | device deficiencies reported from consent to end of study |
| nurses' satisfaction | one month | satisfaction evaluated by questionnaire before and after the inclusions |
| patient satisfaction | one month | satisfaction evaluated by questionnaire before and after the use of experimental device |
| clinical performance of device | one month | performance measured by rate of successful sessions |
Countries
France
Outcome results
None listed